Contract Analytical Testing Laboratory
Contract Analytical Testing Laboratory
Contract Analytical Testing Laboratory
Whether it is for routine analytical release testing or the development of challenging or specialized analytical methods for your large or small molecule, Stegram Pharmaceuticals team of highly experienced analytical chemists use up-to-date, compliant laboratory infrastructure to meet your quality standards. By integrating analytical method development and validation services with API and dosage form manufacturing, we reduce turnaround times for your drug development program and achieve key milestones faster.
Stegram Pharmaceuticals comprehensive analytical services support our integrated services including drug discovery, drug development, process development, contract cGMP API synthesis, and cGMP finished dose manufacturing. Our on-site microbiology services lab is part of our complete analytical service offering.
Whether it is for routine analytical release testing or the development of challenging or specialized analytical methods for your large or small molecule, Stegram Pharmaceuticals team of highly experienced analytical chemists use up-to-date, compliant laboratory infrastructure to meet your quality standards. By integrating analytical method development and validation services with API and dosage form manufacturing, we reduce turnaround times for your drug development program and achieve key milestones faster.
Stegram Pharmaceuticals comprehensive analytical services support our integrated services including drug discovery, drug development, process development, contract cGMP API synthesis, and cGMP finished dose manufacturing. Our on-site microbiology services lab is part of our complete analytical service offering.
Analytical Laboratory
Our Analytical Services area was architecturally designed to house a wide array of analytical equipment. The analytical lab supports the cGMP manufacturing services with analytical method development services, method validations, raw material release testing, in-process testing, finished product release testing as well as stability testing. Dalton utilizes current industry standard equipment including HPLC, GC, LC-MS, SEC-MALS, KF and others to support our customer requirements.
Contract analytical lab services include:
- Analytical Development Services
- Accelerated Stability Services
- Stability Storage and Testing
- Flow Chemistry
- SEC-MALS
- ICP-MS Elemental Analysis
- Microbiology Services
- Chiral analysis (HPLC and GC) and preparative HPLC chiral chromatographic separations allowing detailed characterization of a diverse range of pharmaceutical, biopharmaceutical and synthetic chiral compounds
- Raw Material / Finished Product Testing (including cytotoxic material)
- Reference Standards Certification
- Physical and Wet Chemical Analysis
- Process and Cleaning Validations
- Container / Packaging Testing
- Thin Layer Chromatography (TLC)
- Organic Volatile Impurities (OVI)
- Arsenic
- Melting Point
- Residue on Ignition (ROI)
- Loss on Drying (LOD)
- Elemental Analysis (EA)
- Polymorphism Screening
Some of the analytical equipment we use for large and small molecule analysis includes:
- LC-MS (Liquid chromatography mass spectrometry) – LCQ Classic, LCQ Duo with Electrospray Ionizer (ESI), LCQ Deca
- HPLC
- DAD – Diode Array Detector (UV)
- Variable Wavelength UV Detector
- Conductivity Detection
- Fluorescence Detection
- Evaporative Light Scattering Detection (ELSD)
- SEC-MALS
- GC (Gas Chromatography)
- Flame Ionization Detector (FID)
- Thermal Conductivity Detector (TCD)
- Headspace techniques (USP-OVI)
- Spectroscopy UV / Visible
- Infrared (FTIR)
- Particle Size Analysis
- Polarimetry
- Osmolality
- Oxygen Headspace Analyzer
- Differential Scanning Calorimetry (DSC)
- KF (Volumetric & Coulometric)
- pH
Contract analytical lab services include:
- Analytical Development Services
- Accelerated Stability Services
- Stability Storage and Testing
- Flow Chemistry
- SEC-MALS
- ICP-MS Elemental Analysis
- Microbiology Services
- Chiral analysis (HPLC and GC) and preparative HPLC chiral chromatographic separations allowing detailed characterization of a diverse range of pharmaceutical, biopharmaceutical and synthetic chiral compounds
- Raw Material / Finished Product Testing (including cytotoxic material)
- Reference Standards Certification
- Physical and Wet Chemical Analysis
- Process and Cleaning Validations
- Container / Packaging Testing
- Thin Layer Chromatography (TLC)
- Organic Volatile Impurities (OVI)
- Arsenic
- Melting Point
- Residue on Ignition (ROI)
- Loss on Drying (LOD)
- Elemental Analysis (EA)
- Polymorphism Screening
Some of the analytical equipment we use for large and small molecule analysis includes:
- LC-MS (Liquid chromatography mass spectrometry) – LCQ Classic, LCQ Duo with Electrospray Ionizer (ESI), LCQ Deca
- HPLC
- DAD – Diode Array Detector (UV)
- Variable Wavelength UV Detector
- Conductivity Detection
- Fluorescence Detection
- Evaporative Light Scattering Detection (ELSD)
- SEC-MALS
- GC (Gas Chromatography)
- Flame Ionization Detector (FID)
- Thermal Conductivity Detector (TCD)
- Headspace techniques (USP-OVI)
- Spectroscopy UV / Visible
- Infrared (FTIR)
- Particle Size Analysis
- Polarimetry
- Osmolality
- Oxygen Headspace Analyzer
- Differential Scanning Calorimetry (DSC)
- KF (Volumetric & Coulometric)
- pH
Analytical Development Services
Analytical Development Services
Analytical Development Services
Stegram Pharmaceuticals offers a full range of analytical development services to our customers.
We have extensive experience in the development of robust analytical test methods for raw materials, in-process tests, drug substances, APIs / impurities as well as drug products (including complex injectables).
Stegram Pharmaceuticals also has experience in working with Stress Indicating Assays in support of Stress Degradation Studies.
Our experienced analytical development scientists can accelerate your development program by having the same team work on development of analytical methods for both API and finished products, thereby minimizing the overall development time.
Stegram Pharmaceuticals offers a full range of analytical development services to our customers.
We have extensive experience in the development of robust analytical test methods for raw materials, in-process tests, drug substances, APIs / impurities as well as drug products (including complex injectables).
Stegram Pharmaceuticals also has experience in working with Stress Indicating Assays in support of Stress Degradation Studies.
Our experienced analytical development scientists can accelerate your development program by having the same team work on development of analytical methods for both API and finished products, thereby minimizing the overall development time.
Upon completion of the development, Stegram Pharmaceuticals can qualify or validate the analytical test methods to your rigorous standards, including challenging the linearity, accuracy and precision of the methods, ensuring that the method performs over the desired range.
Stegram Pharmaceuticals is your full service provider of Analytical Development Services.
Structure Elucidation of Impurities
Structure Elucidation of Impurities
Structure Elucidation of Impurities
With over 2,000 high quality research molecules in our catalogue, Stegram Pharmaceuticals has over 30 years of expertise in structure elucidation of unknown synthetic impurities, intermediates, degradants, and excipient-related impurities.
Impurity Screening:
Identification of Unknown impurities of >0.05% abundance using internally developed or client supplied method.
Structure Elucidation Capabilities:
LC/MS/MS, FTIR, HRMS, 1D& 2D NMR, Chiral Chromatography
Isolation Techniques: Preparative HPLC, SPE, SPME, and wet chemistry procedures.
With over 2,000 high quality research molecules in our catalogue, Stegram Pharmaceuticals has over 30 years of expertise in structure elucidation of unknown synthetic impurities, intermediates, degradants, and excipient-related impurities.
Impurity Screening:
Identification of Unknown impurities of >0.05% abundance using internally developed or client supplied method.
Structure Elucidation Capabilities:
LC/MS/MS, FTIR, HRMS, 1D& 2D NMR, Chiral Chromatography
Isolation Techniques: Preparative HPLC, SPE, SPME, and wet chemistry procedures.
Custom Synthesis:
Our creative and highly skilled synthetic chemists can quickly turn around custom synthesis in projects to verify the final structure of the impurity.
Impurity Reference Standards:
Identified compounds can be ultra-purified for use as reference standards for QC analysis and stability impurity monitoring studies.
Timeline:
Reliable preliminary screening in 2-3 weeks or less per sample. Projects can be extended to custom synthesis, structure verification, process development, and small and medium scale production. (Expedited services available upon request).
Deliverables:
Compliant data and executed documents. CoA available upon request.
Microbiology Services
Microbiology Services
Microbiology Services
As an integrated manufacturer of API and finished dose products, including sterile injectables, we understand the critical importance of reliable microbiology testing. Stegram Pharmaceuticals offers a full range of microbiology testing services to support every product need.
Stegram Pharmaceuticals offers the following Microbiological Services:
- Bioburden Analysis
- Environmental Monitoring
- Microscopic Procedures
- Water Testing
- Bacterial Endotoxin Testing
- Bacterial Retention Validation
- Particulate Matter
- Sterility Testing
As an integrated manufacturer of API and finished dose products, including sterile injectables, we understand the critical importance of reliable microbiology testing. Stegram Pharmaceuticals offers a full range of microbiology testing services to support every product need.
Stegram Pharmaceuticals offers the following Microbiological Services:
- Bioburden Analysis
- Environmental Monitoring
- Microscopic Procedures
- Water Testing
- Bacterial Endotoxin Testing
- Bacterial Retention Validation
- Particulate Matter
- Sterility Testing
Microbiology Laboratory
This 350 square foot (32.5 square meter) laboratory accommodates the necessary staff and equipment to support Stegram Pharmaceuticals rigorous environmental monitoring program for the GMP area. Biological safety cabinets and incubators are used for on-site bioburden testing, microbial identification and environmental monitoring of the cGMP area.
Accelerated Stability Testing
Accelerated Stability Testing
Accelerated Stability Testing
Stegram Pharmaceuticals supports its customers’ products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs. Data and trending analysis performed by Stegram Pharmaceuticals stability experts, means results you can rely on. We even offer stability testing programs for your controlled drug products (scheduled drugs).
Our modern laboratory and experienced analysts ensure your stability pulls are performed on time and that the high-quality test results are provided to you on schedule. We can compile and generate detailed stability reports that meet your reporting requirements for commercial products as well as programs designed to support your clinical programs.
Stegram Pharmaceuticals supports its customers’ products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs. Data and trending analysis performed by Stegram Pharmaceuticals stability experts, means results you can rely on. We even offer stability testing programs for your controlled drug products (scheduled drugs).
Our modern laboratory and experienced analysts ensure your stability pulls are performed on time and that the high-quality test results are provided to you on schedule. We can compile and generate detailed stability reports that meet your reporting requirements for commercial products as well as programs designed to support your clinical programs.
All stability programs are maintained in qualified in-house stability chambers that are controlled and monitored 24/7 for any change in Temperature and Humidity and are fully supported with our alarm notification system and backup generator keeping your stability studies safe and secure.
Pharmaceutical Company offers a wide range of ICH compliant stability conditions including:
- 25°C ± 2°C / 60% RH ± 5% RH
- 30°C ± 2°C / 65% RH ± 5% RH
- 40°C ± 2°C / 75% RH ± 5% RH
- 5°C ± 3°C
- -20°C ± 5°C
- Photo-stability ICH Q1B: 14,000 Lux Vis and 200 W/m2 U
We offer a wide range of stability and analytical services:
- Protocol Development
- Development and Evaluation of Stability indicating methods
- Long-Term Stability Testing
- Intermediate Stability testing
- Accelerated Stability Testing
- Formulation Evaluation Stability Testing
- Forced Degradation Studies
- Data and trending analysis
- Controlled Drug Products Stability Testing
- Commercial Product Stability Testing
- Comparator Stability Testing
- Photostability
Pharmaceutical Company offers a wide range of ICH compliant stability conditions including:
- 25°C ± 2°C / 60% RH ± 5% RH
- 30°C ± 2°C / 65% RH ± 5% RH
- 40°C ± 2°C / 75% RH ± 5% RH
- 5°C ± 3°C
- -20°C ± 5°C
- Photo-stability ICH Q1B: 14,000 Lux Vis and 200 W/m2 U
We offer a wide range of stability and analytical services:
- Protocol Development
- Development and Evaluation of Stability indicating methods
- Long-Term Stability Testing
- Intermediate Stability testing
- Accelerated Stability Testing
- Formulation Evaluation Stability Testing
- Forced Degradation Studies
- Data and trending analysis
- Controlled Drug Products Stability Testing
- Commercial Product Stability Testing
- Comparator Stability Testing
- Photostability
Let Stegram Pharmaceuticals be your trusted partner for all of your stability and analytical testing needs.
SEC-MALS
SEC-MALS
SEC-MALS
SEC-MALS (Size Exclusion Chromatography – Multi Angle Light Scattering)
GMP/GLP Large Molecule Testing Services
With the growing number of large molecule products in development, it is more important than ever to be able to characterize your large molecule product with confidence.
That is why Stegram Pharmaceuticals has added GMP/GLP Size Exclusion Chromatography – Multi Angle (Laser) Light Scattering (SEC-MALS) to its analytical services offering.
SEC-MALS is an established analytical method for the absolute determination of molar mass of large molecules. This approach is ideal for molecules with molar masses ranging from 103 to 109 g/mol, and is suitable for many molecule types such as:
- Proteins
- Peptides
- Conjugates
- Polymers
- Biopolymers
SEC-MALS (Size Exclusion Chromatography – Multi Angle Light Scattering)
GMP/GLP Large Molecule Testing Services
With the growing number of large molecule products in development, it is more important than ever to be able to characterize your large molecule product with confidence.
That is why Stegram Pharmaceuticals has added GMP/GLP Size Exclusion Chromatography – Multi Angle (Laser) Light Scattering (SEC-MALS) to its analytical services offering.
SEC-MALS is an established analytical method for the absolute determination of molar mass of large molecules. This approach is ideal for molecules with molar masses ranging from 103 to 109 g/mol, and is suitable for many molecule types such as:
- Proteins
- Peptides
- Conjugates
- Polymers
- Biopolymers
SEC-MALS Advantages
SEC-MALS can replace a number of traditional techniques, such as viscosity, electrophoresis and retention times by HPLC, with a single absolute test.
- Fast –Results in as little as one hour making it viable as an in-process test
- Absolute – Molar mass is an absolute measure, not relative to a standard
- Automated – Efficient and can process multiple samples quickly
- Reliable – Precise and accurate molar mass results
- Established – Accepted GMP/GLP test, no additional regulatory hurdles for validated methods
Stegram Pharmaceuticals SEC-MALS Services
We Develop, Validate and Test:
- GMP/GLP Compliant Services
- Analytical Method Development
- Method Validation
- Release Testing
- In-Process Testing
- Stand-Alone Analytical Testing
SEC-MALS Advantages
SEC-MALS can replace a number of traditional techniques, such as viscosity, electrophoresis and retention times by HPLC, with a single absolute test.
- Fast –Results in as little as one hour making it viable as an in-process test
- Absolute – Molar mass is an absolute measure, not relative to a standard
- Automated – Efficient and can process multiple samples quickly
- Reliable – Precise and accurate molar mass results
- Established – Accepted GMP/GLP test, no additional regulatory hurdles for validated methods
Stegram Pharmaceuticals SEC-MALS Services
We Develop, Validate and Test:
- GMP/GLP Compliant Services
- Analytical Method Development
- Method Validation
- Release Testing
- In-Process Testing
- Stand-Alone Analytical Testing
With a rapid turnaround time and an automated process, Stegram Pharmaceuticals GMP/GLP SEC-MALS services can provide you with the accurate and precise molecular mass results you need for your large molecule.
Stegram Pharmaceuticals uses state of the art Wyatt MALS (light scattering) and Refractive Index (RI) detectors in combination with Agilent HPLCs in our GMP/GLP analytical laboratories. The automated system allows for the efficient testing of multiple samples. With rapidly available test results, SEC-MALS can be a viable option for both your in-process and product testing requirements.
Contact us for more information on our SEC-MALS services.
ICP-MS Elemental Analysis
ICP-MS Elemental Analysis
ICP-MS Elemental Analysis
In accordance with the updated ICH Q3D Guideline for Elemental Impurities, Stegram Pharmaceuticals now offers ICP-MS testing services.
Drug Products have the potential to contain contaminants or elemental residues that may be harmful to the consumer, even in small quantities. It is the responsibility of the manufacturer and distributor to ensure that any hazardous chemicals including heavy metal or elemental impurities meet the current regulatory guidelines for finished products.
With ICP-MS, we can detect:
- Most elements from Li to U except C, N, O, Cl, Br, I and S
- With an optimal detection range from 0.1 ppm to 1% wt & sample size as small as 0.01 g.
- Parts per trillion (ppt) range for many elements in aqueous solutions
The instrument, an Agilent 7800 ICP-MS quadrupole analyzer, is currently validated and ready for use.
We Develop, Validate and Test; Dalton offers:
- GMP Compliant Services
- Analytical Method Development
- Method Validation
- Release Testing
- In-Process Testing
- Stand-Alone Analytical Testing
Contact us for more information on our ICP-MS services.
Integrated Drug Discovery, Development and Manufacturing
Stegram pharmaceutical
72 high Beeches, Banstead, surrey,Sm7 1NW United Kingdom.
reach us at : [email protected]
Phone: +44(0)8712455161
72 high Beeches, Banstead, surrey,Sm7 1NW United Kingdom.
reach us at : [email protected]
Phone: +44(0)8712455161
copyright© 2022 stegrampharma.co.uk